Phase 2 Brain Cancer Trial, Recruiting NCT06465199 Sponsor: Milton S. Hershey Medical Center Condition: Brain Cancer
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Phase 2 Brain Cancer Trial, Recruiting

NCT06465199
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You must have been 26 years old or younger at the time your cancer was diagnosed.
  • You must have one of the following confirmed cancer diagnoses: relapsed or treatment-resistant neuroblastoma, relapsed or treatment-resistant embryonal tumor with multilayer rosettes (ETMR), relapsed or treatment-resistant atypical teratoid rhabdoid tumor (ATRT), newly diagnosed diffuse intrinsic pontine glioma (DIPG), relapsed or treatment-resistant Ewing sarcoma, or relapsed or treatment-resistant osteosarcoma.
  • Your disease must be assessed and staged within 28 days before starting the study drug.
  • For neuroblastoma: your cancer must be high-risk and either came back after standard treatment or did not respond well enough to standard treatment; if you currently have no active disease, you must start the study drug within 60 days of your most recent treatment; if you do have active disease, it must be stable or improving on a recent treatment, and the cancer must not have spread to organs such as the lungs, liver, or brain.
  • For ETMR or ATRT: your cancer must have come back or stopped responding to standard treatments including chemotherapy, radiation, and/or high-dose chemotherapy with stem cell rescue; if you have no active disease, you must start the study drug within 60 days of your most recent treatment; if you have active disease, it must be stable or improving on a recent treatment.
  • For DIPG: you must have a newly diagnosed typical DIPG (confirmed by scan, no tissue biopsy required) and must start the study drug between 30 and 60 days after finishing standard radiation therapy; your cancer must not have spread beyond the brainstem.
  • For Ewing sarcoma or osteosarcoma: your cancer must have come back or stopped responding to standard treatment (chemotherapy plus surgery or radiation); if you have no active disease, you must start the study drug within 60 days of your most recent treatment; if you have active disease, it must be stable or improving on a recent treatment.
  • You must be able to swallow capsules.
  • If you have cancer affecting your brain or spine and are taking steroids, your steroid dose must have been stable for at least one week, and you must not have worsening fluid buildup in the brain at the time of enrollment.
  • You must have recovered from the side effects of any previous cancer treatments, and enough time must have passed since those treatments (the exact waiting period depends on the type of treatment — confirm specific timelines with the trial site).
  • You must have a performance score of 60 or higher on a standard activity scale, meaning you are able to carry out at least some daily activities (confirm with trial site).
  • Your blood, liver, heart, and kidney function must all be within acceptable ranges as measured by blood tests and scans at the time of enrollment (confirm specific values with trial site).
  • If you could become pregnant, you must have a negative pregnancy test before joining and agree to use effective birth control during the trial; if you are breastfeeding, you must agree to stop.
  • You (or your legal guardian) must be willing and able to sign an informed consent form.

Who may not be able to join:

  • Your body surface area (a measurement related to your height and weight) must not be below a certain minimum size — this is especially relevant for very young or very small children (confirm with trial site).
  • You are currently taking part in another clinical trial involving an experimental drug.
  • You are currently receiving any other cancer treatment.
  • You have an infection that is not well controlled at the time of enrollment.
  • In the opinion of the study doctors, you may not be able to safely follow the study's monitoring and safety requirements.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 8 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Giselle Saulnier Sholler, MD, Penn State Health Children's Hospital

Phone: 7175310003

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Milton S. Hershey Medical Center
Registry
ClinicalTrials.gov
Start date
13 May 2026
Est. completion
1 May 2033

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Phase I- Number of Participants with Adverse Events as a Measure of Safety and Tolerability; Phase II- Number of Cohort 1 participants with progression free survival (PFS) during study; Phase II- Number of Cohort 2-4 participants with progression free survival (PFS) during study

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 8 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov